Medical Device Manufacturer · DK , Denmark

Polystan A/S - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1991

Recent clearances: SAFE MINI, SAFE MICRO

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Polystan A/S Cardiovascular ✕

6 devices

1-6 of 6

Cleared Dec 04, 2002

PEDIATRIC ARTERIAL CANNULA

Cardiovascular · 65d

Cleared Aug 14, 2002

SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010

Cardiovascular · 338d

Cleared Aug 06, 2002

SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045

Cardiovascular · 22d

Cleared Oct 13, 2000

Cardiovascular · 942d

Cleared Feb 04, 1997

Cardiovascular · 531d

Cleared Dec 04, 1991

Cardiovascular · 208d